Cleared Traditional

K921495 - DIA STRIPS SYSTEM, MODIFIED

K921495 is an FDA 510(k) clearance for DIA STRIPS SYSTEM, manufactured by Symcon Intl., Inc.. The device is a Class 2 Chemistry device with product code JIO cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K921495 · Symcon Intl., Inc. · Chemistry device
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Jul 1992
Decision
137d
Days
Class 2
Risk

K921495 is an FDA 510(k) clearance for the DIA STRIPS SYSTEM, MODIFIED. Classified as Blood, Occult, Colorimetric, In Urine (product code JIO), Class II - Special Controls.

Submitted by Symcon Intl., Inc. (Lenexa, US). The FDA issued a Cleared decision on July 21, 1992 after a review of 137 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.6550 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Symcon Intl., Inc. devices

FDA 510(k) Submission Details - K921495

510(k) Number K921495 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1992
Decision Date July 21, 1992
Days to Decision 137 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d slower than avg
Panel avg: 88d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIO Device Classification - Class 2, Special Controls

Product Code JIO Blood, Occult, Colorimetric, In Urine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JIO Blood, Occult, Colorimetric, In Urine

All 8
Devices cleared under the same product code (JIO) and FDA review panel - the closest regulatory comparables to K921495.
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URS-1B (BLOOD TEST)
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K913005 · Remel Co. · Sep 1991
HEMASTIX REAGENT STRIPS
K905396 · Heraeus Kulzer, Inc. · Feb 1991